PRO MAX, System, 110V Pro Max System 110V black
PRO MAX, System, 110V Pro Max System 110V black (ND_PRD00475-00) is a medical device (FDA Class II) made by Endymed Medical Ltd, cleared under FDA 510(k) K242996 on 10 Jun 2025 and listed in FDA GUDID since 17 Nov 2025 (UDI-DI 07290016814569), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290016814569 | Date17 Nov 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK242996 | Date10 Jun 2025 | StatusActive |
Official records
- AccessGUDID record 07290016814569
- FDA 510(k) database K242996
Across registries
- FDA 510(k) K242996 decided 10 Jun 2025 Active
- FDA GUDID UDI-DI 07290016814569 listed 17 Nov 2025 Listed
Timeline
- Cleared FDA 510(k) K242996
- Listed FDA GUDID 07290016814569
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PRO MAX, System, 110V
- Generic name
- Radio-frequency skin surface treatment/fat liquefaction system control unit
- Model / Ref / Catalog
- Pro Max System 110V black, ND_PRD00475-00
- Primary DI / UDI-DI
- 07290016814569
- 510(k) Number
- FDA product code
- GEI, OUH, PBX
- GMDN term
- Radio-frequency skin surface treatment/fat liquefaction system control unit
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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